End Stage Renal DiseaseWAK US 1NCT02280005
24 Hour Use of the Wearable Artificial Kidney
A study testing WAK Treatment in people with End Stage Renal Disease, run by Blood Purification Technologies, Inc. at 1 site in United States.
Trial summary
This is a prospective, interventional study designed to provide preliminary data on the human use of the WAK. Up to 10 subjects currently receiving intermittent hemodialysis (HD) treatment three times per week for end-stage renal disease (ESRD) via an indwelling tunneled catheter will be studied. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- WAK Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient willing and competent to sign the approved informed consent.
- Patient must be at least 21 years of age or older.*
- Patient must weigh between 45 and 100kg, inclusive.*
- Patient must have End Stage Renal Disease and currently undergoing consistent intermittent HD at least 3 times a week for at least 3 months prior to being enrolled.*
- Vascular access must be through a functioning double lumen catheter with no thrombolytic therapy or clotting of the catheter within the past 4 weeks.*
- Willing to comply with the requirements of experimental treatment with the WAK for up to 24 hours.
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- Expected survival of no less than 6 months.*
- Consent to allow review of their medical records by the investigators, and monitors.
- Fluency in English
- Hemoglobin level ≥ 9.0 g/dL prior to WAK treatment
Who cannot join
- • Anticipating or scheduled for a living related donor kidney transplant in less than 2 months.**
- History (within the 12 weeks prior to the study) of cardiovascular events including:*
- Unstable angina
- Myocardial Infarction
- Stroke
- Clinical Significant Arrhythmia
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- Life threatening arrhythmia within the past 30 days*
- Severe intradialytic hypotension within the last 30 days*
- Shock within the last 30 days*
- Hemodynamic instability as demonstrated by repeated episodes of hypotension or hypertension requiring intervention by dialysis personnel or representing a present hazard to the patient*
- Seizure disorder requiring active treatment for a seizure episode during the last 6 months*
- Major Surgery (excluding vascular access surgery) within the past 30 days *
- Currently receiving intravenous antibiotic therapy for systemic infection*
- Clinical evidence of metastatic malignancy, receiving radiation or chemotherapy, within the past 365 days*
- Active bleeding*
- Hematological disease (e.g. malignancies, hemolytic anemia, thrombocytopenia), and other conditions that may interfere of confuse the data obtained from this trial.*
- Current enrollment in another investigational device or drug trial.**
- Subject is pregnant (e.g., positive HCG test) or is breast feeding.
- Subject has any disorder (excluding illiteracy or visual impairment) that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures.*
- Allergy to heparin or ethylene oxide.*
- Hypertension deemed uncontrolled, at the discretion of the investigator, within the past 30 days.*
- Has an implantable electronic device (e.g. pacemaker)*
- As documented in patient medical history (see attached). **Patient self-report.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington
Seattle, Washington, 98195U
About this study
Official title: First 24 Hour Human Trial of the Wearable Artificial Kidney
This is a prospective, interventional study designed to provide preliminary data on the human use of the WAK. Up to 10 subjects currently receiving intermittent hemodialysis (HD) treatment three times per week for end-stage renal disease (ESRD) via an indwelling tunneled catheter will be studied.
Read the detailed description
Subjects will undergo 24 hours in-hospital treatment with the Wearable Artificial Kidney (WAK). Up to 10 subjects with ESRD will complete the protocol in its entirety.
The objective of this protocol is to provide additional preliminary data supporting the hypothesis that the WAK safely and effectively delivers dialysis therapy that is at least equal to the current standard of care for treatment of ESRD using conventional machines for thrice weekly hemodialysis treatments. These objectives would be accomplished by absence of adverse events during treatment with the WAK, along with effective removal of fluid and solutes at least equal to those delivered with conventional currently used dialysis machines. The WAK will be the only investigational device used in this study.
The reason for this trial is to advance the eventual approval of this device to be legally commercialized as it potentially may respond to the unmet public health needs to improve outcomes and reduce costs in the treatment of ESRD patients.
- Conditions
- End Stage Renal Disease
- Being tested
- WAK Treatment
- Keywords
- Dialysis, Renal Failure, Wearable, Artificial Kidney, Hemodialysis
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WAK TreatmentDevice
Hemodialysis with WAK device.
| Study group | Role | What they receive |
|---|---|---|
| WAK Treatment | Experimental | Use of experimental device. Receives: Device: WAK Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 24 hours
Subject vital signs as a Measure of Safety and Tolerability
Measured: 24 hours
Satisfaction survey as a Measure of Safety and Tolerability
Measured: Post Treatment
Blood creatinine as a Measure of Safety and Tolerability
Measured: 24 hours
Dialysate toxin load as a Measure of Safety and Tolerability
Measured: 24 hours
Blood electrolytes as a Measure of Safety and Tolerability
Measured: 24 Hours
Secondary outcomes (5)
Blood urea levels
Measured: 24 hours
Dialysate Urea Levels
Measured: 24 hours
Blood creatinine levels
Measured: 24 hours
Dialysate creatinine levels
Measured: 24 Hours
Volume of spent dialysate
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blood Purification Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Washington, Wearable Artificial Kidney Foundation
- Responsible party
- Sponsor
- Investigators
- Jonathan Himmelfarb, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280005
- Sponsor's protocol ID
- WAK Seattle
- Acronym
- WAK US 1
- Status last verified
- Jul 2017
- First submitted
- 19 Sep 2014
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gura V, Rivara MB, Bieber S, Munshi R, Smith NC, Linke L, Kundzins J, Beizai M, Ezon C, Kessler L, Himmelfarb J. A wearable artificial kidney for patients with end-stage renal disease. JCI Insight. 2016 Jun 2;1(8):e86397. doi: 10.1172/jci.insight.86397.
PubMed 27398407
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First 24 Hour Human Trial of the Wearable Artificial Kidney
- ClinicalTrials.gov ID
- NCT02280005
- Acronym / sponsor ID
- WAK US 1 / WAK Seattle
- Conditions
- End Stage Renal Disease
- Keywords
- Dialysis, Renal Failure, Wearable, Artificial Kidney, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Blood Purification Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Washington, Wearable Artificial Kidney Foundation
- Study start
- Oct 2014 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, interventional study designed to provide preliminary data on the human use of the WAK. Up to 10 subjects currently receiving intermittent hemodialysis (HD) treatment three times per week for end-stage renal disease (ESRD) via an indwelling tunneled catheter will be studied.
Detailed description
Subjects will undergo 24 hours in-hospital treatment with the Wearable Artificial Kidney (WAK). Up to 10 subjects with ESRD will complete the protocol in its entirety.
The objective of this protocol is to provide additional preliminary data supporting the hypothesis that the WAK safely and effectively delivers dialysis therapy that is at least equal to the current standard of care for treatment of ESRD using conventional machines for thrice weekly hemodialysis treatments. These objectives would be accomplished by absence of adverse events during treatment with the WAK, along with effective removal of fluid and solutes at least equal to those delivered with conventional currently used dialysis machines. The WAK will be the only investigational device used in this study.
The reason for this trial is to advance the eventual approval of this device to be legally commercialized as it potentially may respond to the unmet public health needs to improve outcomes and reduce costs in the treatment of ESRD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WAK Treatment | Experimental | Device: WAK TreatmentUse of experimental device. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient willing and competent to sign the approved informed consent.
- Patient must be at least 21 years of age or older.*
- Patient must weigh between 45 and 100kg, inclusive.*
- Patient must have End Stage Renal Disease and currently undergoing consistent intermittent HD at least 3 times a week for at least 3 months prior to being enrolled.*
- Vascular access must be through a functioning double lumen catheter with no thrombolytic therapy or clotting of the catheter within the past 4 weeks.*
Key exclusion criteria (23 listed)
- • Anticipating or scheduled for a living related donor kidney transplant in less than 2 months.**
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WAK TreatmentHemodialysis with WAK device. | Device | WAK Treatment |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 24 hours
Subject vital signs as a Measure of Safety and Tolerability
Time frame: 24 hours
Satisfaction survey as a Measure of Safety and Tolerability
Time frame: Post Treatment
Blood creatinine as a Measure of Safety and Tolerability
Time frame: 24 hours
Dialysate toxin load as a Measure of Safety and Tolerability
Time frame: 24 hours
Blood electrolytes as a Measure of Safety and Tolerability
Time frame: 24 Hours
5 secondary outcomes
Blood urea levels
Time frame: 24 hours
Dialysate Urea Levels
Time frame: 24 hours
Blood creatinine levels
Time frame: 24 hours
Dialysate creatinine levels
Time frame: 24 Hours
Volume of spent dialysate
Time frame: 24 Hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Derived from this study: PubMed 27398407Gura V, Rivara MB, Bieber S, Munshi R, Smith NC, Linke L, Kundzins J, Beizai M, Ezon C, Kessler L, Himmelfarb J. A wearable artificial kidney for patients with end-stage renal disease. JCI Insight. 2016 Jun 2;1(8):e86397. doi: 10.1172/jci.insight.86397.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Himmelfarb, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WAK Treatment in people with End Stage Renal Disease, run by Blood Purification Technologies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 24 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02280005, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2017.